BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ZIMMER ZMR HIP STEM

    MDR report key: 1051819 · Received May 23, 2008

    Report

    Report Number
    1822565-2008-00269
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 17, 2008
    Report Date
    April 24, 2008
    Manufacturer
    ZIMMER, INC.
    Product Code
    JDI
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL SUMMARY: THE STEM HAS FRACTURED. THE PACKAGE INSERT CONTAINS STATEMENTS WARNING THAT DEVICE FRACTURES MAY OCCUR WHERE EXCESSIVE PT WEIGHT, EXCESSIVE PT ACTIVITY, OR LACK OR PROXIMAL SUPPORT OF THE BODY ARE INVOLVED. NOT ALL OF THESE FACTORS ARE KNOWN FOR THIS CASE. THERE IS NO DEFINITIVE INDICATION THAT DESIGN OR MFR OF THE DEVICE CONTRIBUTED TO THE OUTCOME DESCRIBED HERE. RISK MGMT ACTIVITY HAS BEEN INITIATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THIS REPORT WILL BE AMENDED. NO PROD WAS RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS WAS ALSO NOT POSSIBLE AS THE PROD AND/OR LOT #S REQUIRED FOR RETRIEVAL WERE UNAVAILABLE. IT IS NOT SUSPECTED THAT THE PROD FAILED TO MEET SPECS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY EVIDENCE OF PROD CONTRIBUTION TO THE REPORTED PROBLEM. BASE ON THE AVAILABLE INFO, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. SHOULD ADD'L SUBSTANTIVE INFO BE REC'D, THE COMPLAINT WILL BE RE-OPENED. ZIMMER CONSIDERS THE INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT IS REPORTED THAT PT UNDERWENT HIP REPLACEMENT IN 2006, PT WAS REVISED IN 2008 DUE TO STEM FRACTURING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN ZIMMER ZMR HIP STEM HIP PROSTHESIS JDI ZIMMER, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R CATALOG # UNK